中成药中化学药成分含量均匀度限度的研究

Research on the Limit of Content Uniformity Test of Chemical Component of Chinese Patent Drug

目的:为合理制定中成药含量均匀度限度提供依据。方法:以消渴丸为基础药物,测定100丸消渴丸中格列本脲的含量。在此试验数据基础上,采用随机正态分布函数生成大量的符合正态分布的模拟含量数据,采用统计学方法,研究服用剂量与标准差及合格率之间的相关性。结果:服用多个单位剂量后的标准差与服用个数的平方根成反比,按服用个数组合后的含量合格率明显提高。结论:中成药含量均匀度限度可根据服用个数合理放宽;推荐按服用个数组合后测试。

OBJECTIVE： To provide reference for formulating the rational limit of content uniformity test of Chinese patent drug. METHODS： Using Xiaoke pills as base drug, the contents of glimepiride in 100 pills of Xiaoke pills were determined. Based on the data of pretest, the data of preparation produced by computer simulation with random normal distribution function and the re- lationship between the dose of preparation being taken and the standard deviation or passing rate had been obtained by statistics. RE- SULTS： Standard deviation was inversely proportional to the square root of the number of preparation being taken. The percent of pass increased obviously with the assembled of the number of preparation being taken. CONCLUSION： The limit of content unifor- mity test of Chinese patent drug should be relaxed suitably according to the number of preparation being taken. It is recommended that the sampling should be assembled according to the number of the preparation being taken in the content uniformity test.